Johnson & Johnson’s baby shampoo samples failed quality tests in the Indian state of Rajasthan, according to a notice from the state’s drugs watchdog. The state’s findings were rejected by the U.S. product manufacturer.
This comes just a few months after Indian authorities launched an investigation into J&J’s Baby Powder to see if it contains cancer-causing asbestos. J&J said in late February it had resumed production of baby talc after government tests found no asbestos in the product.
The Rajasthan Drugs Control Organisation’s notice dated March 5 said that the samples of J&J’s baby shampoo taken from two batches had failed the quality test as they contained “harmful ingredients.” It did not elaborate, according to Reuters.
A J&J spokeswoman said that the results it received from the watchdog indicated that formaldehyde had been discovered in the samples.
Sources told Livemint.com that the samples contained formaldehyde, which is classified as a human carcinogen by the International Agency for Research on Cancer (IARC).
Formaldehyde, used in making building materials, is a known carcinogen. It was also long used for embalming bodies.
The Indian state’s regulatory body said some of the samples are “not a standard quality,” Livemint reported.
The Indian Drugs Control Organization asked state drug controllers to withdraw the baby shampoo from the market. “The samples failed the quality tests. The company will have to reply after which action will be taken as per the Drugs and Cosmetics Act,” a senior official with the agency told the news outlet.
“The samples of cosmetics contains harmful ingredients,” the report of samples also stated.
Meanwhile, officials “have found a higher amount of formaldehyde [than stated by the company] in J&J’s shampoos and the company has been informed about the abnormality,” Rajasthan drug controller Raja Ram Sharma told ThePrint publication.
J&J Rejects Findings
“We do not accept the interim results given to us, which mentioned samples to ‘contain harmful ingredients- identification positive for formaldehyde,’” a spokeswoman for the company told Reuters.
“We unequivocally maintain that our products are safe and our assurance process is amongst the most rigorous in the world,” the J&J spokeswoman elaborated, adding that the firm has contested the Indian state’s findings.
The government analyses, she said, were based on “unknown and unspecified methods,” Reuters reported.
The two batches of the baby shampoo tested are due to expire in September 2021 and were manufactured at the company’s plant in the northern state of Himachal Pradesh, according to the watchdog’s notice.
“We have confirmed to the Indian authorities that we do not add formaldehyde as an ingredient in our shampoo nor does Johnson’s baby shampoo contain any ingredient that can release formaldehyde over time,” the company spokeswoman said.
The federal regulator and its counterparts in Indian states launched an investigation into J&J’s Baby Powder following a Reuters report in December that the firm knew for decades that cancer-causing asbestos could be found in the product.
J&J has described the Reuters article as “one-sided, false and inflammatory.”
J&J’s Baby Powder is one of the biggest foreign brands in the country. The company leads sales in the Indian baby and child toiletries market, according to market research provider Euromonitor.
J&J said in August that it had removed chemicals in its baby care products to make them safer.
“The portfolio of ingredients was reduced by more than 50%, and all baby products have been designed for gentle care with no parabens, phthalates, formaldehyde-releasing preservatives and sulfates. Even Johnson’s shampoo is no longer its signature golden hue, but instead a clear formula packaged in a translucent yellow bottle for a transparent look and feel,” the company said last year.
In 2014, the company reportedly said it would remake its shampoo and other products after formaldehyde and 1,4-dioxane were found.
The New York Times in 2014 reported that J&J promised that “the products no longer contain [the] two potentially harmful chemicals, formaldehyde, and 1,4-dioxane, that have come under increasing scrutiny by consumers and environmental groups.”
“Johnson & Johnson has removed the preservatives that release formaldehyde, and said it has reduced the levels of 1,4-dioxane to very limited trace amounts, from one to four parts per million,” the report stated.
Reuters contributed to this report.